21 CFR 862.1045
§ 862.1045 Aldosterone test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1045, § 862.1045 Aldosterone test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89042
- Permanent ID
ys:prov:89042@1- SHA-256
1b26d181760c57f90835bc3f8a83c7d59f3763f39d2d70ab531e1f97741ac106
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
(b) Classification. Class II.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.